The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Q Series Diagnostic Ultrasound System.
Device ID | K153085 |
510k Number | K153085 |
Device Name: | Q Series Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | CHISON MEDICAL IMAGING CO., LTD. NO.228, CHANGJIANG EAST ROAD, BLOCK 51 AND 53, PHASE 5 INDUSTRIAL PARK SHOUFA Wuxi, CN 214142 |
Contact | Qifei Liu |
Correspondent | Bob Leiker LEIKER REGULATORY & QUALITY CONSULTING 4157 North Del Rey Ave Clovis, CA 93619 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-26 |
Decision Date | 2015-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06945121409681 | K153085 | 000 |
06945121400237 | K153085 | 000 |
06945121400220 | K153085 | 000 |
06945121400213 | K153085 | 000 |
06945121400206 | K153085 | 000 |
06945121400190 | K153085 | 000 |
06945121400183 | K153085 | 000 |
06945121400176 | K153085 | 000 |
06945121400169 | K153085 | 000 |
06945121400152 | K153085 | 000 |
06945121400145 | K153085 | 000 |
06945121400138 | K153085 | 000 |
06945121400121 | K153085 | 000 |
06945121400114 | K153085 | 000 |
06945121400107 | K153085 | 000 |
06945121400060 | K153085 | 000 |
06945121400244 | K153085 | 000 |
06945121400251 | K153085 | 000 |
06945121409445 | K153085 | 000 |
06945121409025 | K153085 | 000 |
06945121403306 | K153085 | 000 |
06945121400374 | K153085 | 000 |
06945121400367 | K153085 | 000 |
06945121400350 | K153085 | 000 |
06945121400343 | K153085 | 000 |
06945121400336 | K153085 | 000 |
06945121400329 | K153085 | 000 |
06945121400312 | K153085 | 000 |
06945121400305 | K153085 | 000 |
06945121400299 | K153085 | 000 |
06945121400282 | K153085 | 000 |
06945121400275 | K153085 | 000 |
06945121400268 | K153085 | 000 |
06945121401241 | K153085 | 000 |